A device for endo-cavitary aspiration comprises:

an elongated, first flexible tubular element with a closed proximal end, featuring multiple holes,

a hollow tubular element with an elongated helical shape connected to the distal end of the first tubular element, designed for suction,

at least one perforated inflatable balloon,

at least one elongated, flexible hollow tubular element passing through one or more holes in the closed proximal end, connected to the balloon for inflation or deflation via fluid introduction,

another elongated, flexible hollow tubular element passing through one or more holes in the closed proximal end, connected to the balloon and a hollow tubular suction element passing through the first element for suction,

The device is distinguished by the inflatable balloon, which, when positioned within a venous lumen and inflated, completely occludes the venous lumen, permitting blood passage toward the hollow tubular suction element through the balloon's holes.

An endo-cavitary aspiration system includes the device, a controller for managing balloon filling and internal pressure, an extracorporeal circulation device, and a vacuum generation device for aspiration. Additional advantages and features are detailed in the description (Figs. 1 and 2).

Fig. 1

Endo-cavitary suction device application on pulmonary vein

Fig. 2

Endo-cavitary suction device sketch, design and component description

Function and application

In one configuration, multiple balloons, preferably at least 1,2, 3, or 4, can be assembled onto the suction line within the first element either before or during the operation, depending on the desired anchoring quantity to the pulmonary veins (Fig. 1). Blood entering the balloon holes is directed into the suction line, enabling selective anchoring based on visual bleeding and the severity of venous return on the pulmonary veins. The elliptical-shaped balloon, with a filling volume of 1 to 10 ml (preferably 5 ml), generates a pressure of 150 to 180 mmHg when inflated, ensuring a hermetic blood seal within the venous lumen, aiding in both aspiration and physically isolating bleeding for optimal surgical field visualization. In this embodiment, the balloon, the element connected to it, and the hollow tubular suction element passing through the first element are constructed from a polymeric material, preferably polyurethane, known for its high pressure resistance, biocompatibility, and sustainability. The balloon's internal pressure, when inflated, achieves 150 to 180 mmHg in the pulmonary venous lumen, maintaining a hermetic blood seal and promoting bleeding isolation for enhanced visualization. The balloon design includes three medial holes and a central hole, strategically placed to facilitate blood aspiration. Different hole numbers and arrangements are possible, but homogeneous blood aspiration management is preferable. To aid identification, each balloon and its associated filling/deflating line are color-coded.

The fluid delivery device for helium administration and pressure monitoring comprises a helium cylinder, a management monitor, and a hardware system providing closed-circuit helium delivery to the balloons based on the color codes, as specified by the surgeon. Additionally, the element connected to the balloon and the hollow tubular suction element may incorporate an internal metal shape memory structure, optimizing space usage during device use without the need for cumbersome syringes. Nitinol, a shape memory alloy, is a suitable material for this purpose.

The element connected to the balloon and the hollow tubular suction element have a diameter of about 0.3 mm to 3.3 mm, preferably 1.67 mm (1 to 10 Fr, preferably 5 Fr). The first flexible tubular element has a diameter of about 3.3 mm to 10 mm, preferably 6.7 mm (10 Fr to 30 Fr, preferably 20 Fr). A fixing system is included inside the first element in this device configuration (Fig. 2).

Suction management

The present invention introduces a suction device known as the "Roller pump for endo-cavitary aspiration," employing a roller mechanism to generate the required vacuum for endo-cavitary aspiration within the realm of "Extracorporeal Circulation Techniques." These techniques involve temporarily diverting blood from the body through a pump system, oxygenating it via a blood oxygenation unit, such as a membrane oxygenator. Typically utilized in conventional extracorporeal circulation processes, the roller pump manages suction [10]. Additionally, the device allows for the incorporation of "Venturi effect devices," exploiting Bernoulli's principle to create a vacuum in a fluidic system. The Venturi effect is based on the relationship between fluid velocity and pressure, utilizing a duct with narrowing and widening sections. This effect can be harnessed to either suction or push fluids depending on the application. In the context of venous return, the Venturi effect device can aspirate blood or other fluids from the venous system [11]. Furthermore, the present invention introduces the concept of a "negative pressure centrifugal pump," utilizing centrifugal force to propel fluid through the system. The term "negative pressure" signifies the creation of a vacuum in the venous line due to the negative pressure effect generated by the centrifugal pump, occurring prior to the conventional venous bubble trap [12].